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Explore how oncology developers are adapting to a highly competitive and uncertain oncology therapeutic landscape. .png)
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Today’s Big NewsNov 1, 2024 |
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Wednesday, November 13 , 2024 | 10am ET / 7am PT Join industry experts to gain insights pertinent to efficient and effective drug development. Understand and execute a risk-based critical thinking approach related to injectable drug packaging and delivery. Register now. 
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| By Fraiser Kansteiner Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair. |
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By Conor Hale The company estimates the abdominal procedure is performed more than 90% of the time in the outpatient setting. |
By Gabrielle Masson Kymera Therapeutics is pivoting its focus from oncology to immunology, with plans to only develop cancer programs beyond phase 1 through partnerships. |
By Angus Liu An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. Now, less than a year later, the FDA is reconsidering those serious safety warnings with plans to potentially change them, CBER Director Peter Marks, M.D., Ph.D., said in an interview with Fierce Pharma. |
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Tuesday, November 12, 2024 | 2pm ET / 11am PT Major breakthroughs have been made recently in the research and development of Alzheimer’s disease. With a stronger understanding of disease pathology, new therapeutic pathways and the launch of the first disease-modifying treatments, join us to learn more about what the future holds in Alzheimer’s disease therapeutic development. Register now. 
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By Darren Incorvaia,Zoey Becker Biogen is tapping some top pharma talent to lead its medical efforts. Daniel Quirk, M.D., is the biotech’s new chief medical officer and head of medical affairs. Quirk formerly served as a senior vice president at BMS, including in worldwide medical affairs for immunology and neuroscience and in U.S. medical affairs. |
By Kevin Dunleavy Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexicon’s Zynquista (sotagliflozin) has had difficulty negotiating regulatory hurdles. On Halloween, Lexicon was haunted again as an FDA advisory committee voted 11-3 to reject Zynquista as an accompanying medication to insulin for those with type 1 diabetes (T1D). |
By Andrea Park Not long after Basel, Switzerland, was selected as the next host of the annual Eurovision Song Contest, hometown pharma Novartis is chiming in. |
By Nick Paul Taylor The week after seeing its partner Roche cut and run, UCB has reported the failure of its anti-tau antibody bepranemab to improve cognition and function in people with early Alzheimer’s disease. But UCB looked past the primary endpoint miss and focused on other results that left it “deeply encouraged” by the trial. |
By Fraiser Kansteiner A trio of antitrust complaints stretching back to 2016 have yielded a payoff, with generic drugmakers Heritage Pharmaceuticals and Apotex now on the hook to lay out a combined $49.1 million in settlement charges. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy. |
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Thursday, November 14, 2024 | 11am ET / 8am PT Join us for a deep dive into the development and manufacturing of monoclonal antibodies. We’ll explore an industry case study, providing access to key findings, top strategies and solutions for enhancing productivity and efficiency in mAb production. Don’t miss out on important insights, register now. 
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Whitepaper Unlock the secrets to faster, cost-effective biologics production with intensified biomanufacturing – download the whitepaper and power up your bioprocessing game! Sponsored by: Syngene International Ltd. |
Whitepaper Discover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results. Sponsored by: WCG |
Whitepaper Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
eBook Need the superpowers to select the right lab equipment? Sponsored by: PHC Corporation of North America |
Whitepaper Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future directions with an emphasis on the upstream aspects. Sponsored by: Lonza |
Whitepaper How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights. Presented by: Blue Matter |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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| The Lighthouse at Pier 61 in New York City |
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